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Trial record 13 of 1430 for:    Hematologic neoplasm

Therapeutic Education in Physical Activity (ETAF) (ETAF)

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ClinicalTrials.gov Identifier: NCT03403075
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
GRADE Onlus
University of Modena and Reggio Emilia
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS

Brief Summary:

To date, studies published on multidimensional rehabilitation programs are addressed to patients with different types of cancer and, frequently, these studies only include a limited number of patients with blood neoplasms. So, there is no evidence of the effectiveness of multidimensional rehabilitation programs in this particular category of patients. A systematic review of the effectiveness of aerobic exercise alone, not associated with therapeutic education, has recently been conducted in adult individuals with hematological malignancies (reference 25386666). The review highlighted the effectiveness of physical activity on the quality of life of the target population. However, the medium and long term effects that physical exercise have on other clinically relevant endpoints, such as fatigue, psychological distress, and physical performance level, remain to be clarified. Thus, it is important to investigate the effectiveness of multidimensional interventions that integrate physical activity to therapeutic education targeted at the specific needs of individuals with blood neoplasm.

The aim of this study is to evaluate, in blood cancer patients, the feasibility of a therapeutic education program associated with physical activity, and to verify its effect by a long-term follow-up.


Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Behavioral: ETAF Behavioral: Usual care Not Applicable

Detailed Description:

This is a randomized controlled pilot study • Control Group will be offered usual care (UC), which includes two sessions of therapeutic education delivered in small groups. In these educational sessions, patients are provided with useful information on communication strategies, problem solving strategies, recognition and management of symptoms and the management of any aids/orthoses provided in everyday life, etc. In the meetings, it will be emphasized the importance of maintaining an active lifestyle as much as possible by encouraging involvement in physical activity even during the cancer treatment period.

Written information material that summarizes the concepts addressed during group meetings will be provided.

• Intervention group will be offered therapeutic education as described for the control group, plus 6 individual sessions of therapeutic education and physical activity (ETAF). The 6 individual session will be held by a physiotherapist dedicated to the study, on a weekly / bi-weekly basis, according to the objectives set and the needs of the patient.

In these sessions, the topics already discussed in group will be deepened, personalizing them according to the patient's characteristics. Furthermore, personalized physical activity is planned, taking into account the context of execution, the clinical condition and the patient's preferences. Patients will be trained to build an action plan aimed at self-plan physical activities and a diary will be provided to monitor the physical activity carried out autonomously.

Written information material that summarizes the concepts addressed during group and individual sessions will be provided.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Therapy as "Drug, Non-drug"
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Care

Control Group will be offered usual care (UC), plus two sessions of therapeutic education delivered in small groups. In these educational sessions, patients are provided with useful information on communication strategies, problem solving strategies, recognition and management of symptoms and the management of any aids/orthoses provided in everyday life, etc. In the meetings, it will be emphasized the importance of maintaining an active lifestyle as much as possible by encouraging involvement in physical activity even during the cancer treatment period.

Written information material that summarizes the concepts addressed during group meetings will be provided.

Behavioral: Usual care
Usual care

Experimental: ETAF: Therapeutic Education Physical Activity

Intervention group will perform UC, and the two sessions of therapeutic education delivered in small group, as for the Control Group. The Intervention group will also provided for 6 individual sessions of therapeutic education and physical activity held by physiotherapists dedicated to the study, according to the patients' needs and objectives.

In these sessions, the topics discussed in group will be deepened, personalizing them according to the patient's characteristics. Furthermore, personalized physical activity is planned, taking into account the context of execution, the clinical condition and the patient's preferences. The patient will be trained to build an action plan aimed at self-plan physical activities and a diary will be provided to monitor the physical activity carried out autonomously.

Written information material that summarizes the concepts addressed during group and individual sessions will be provided.

Behavioral: ETAF
Therapeutic education and Physical activity




Primary Outcome Measures :
  1. Rate of adherence to ETAF [ Time Frame: 18 months (on average) - through study completion ]
    rate of adherence to experimental intervention: ratio between planned intervention and actual intervention (process indicator).


Secondary Outcome Measures :
  1. Effect size on Fatigue [ Time Frame: 6 months ]
    The size of the effect of ETAF, compared to the usual care, will be estimated on cancer-related fatigue (FACIT Fatigue Scale);

  2. Effect size on QoL [ Time Frame: 6 months ]
    The size of the effect of ETAF, compared to the usual care, will also be estimated on quality of life (EORTC Quality of life Questionnaire-C30);

  3. Effect size Psychological distress [ Time Frame: 6 months ]
    The size of the effect of ETAF, compared to the usual care, will also be estimated on psychological distress (NCCN Distress Thermometer and Problem list for patients);

  4. Effect size on Physical function [ Time Frame: 6 months ]
    The size of the effect of ETAF, compared to the usual care, will also be estimated on Physical function (Time up and go and 6MWT)


Other Outcome Measures:
  1. Effect of patient education - adherence [ Time Frame: 6 months ]

    The effect of the educational intervention will be assessed through:

    - degree of patient's adherence to an active lifestyle (Kirkpatrick's taxonomy level 4) (Kirkpatrick, 1996).


  2. Effect of patient education - satisfaction [ Time Frame: 6 months ]

    The effect of the educational intervention will be assessed through:

    - degree of satisfaction of the patient involved in the study and perception of the utility of the treatment provided (Kirkpatrick's taxonomy level 1) (Kirkpatrick, 1996).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First diagnosis of blood cancer or early relapse of blood cancer

Exclusion Criteria:

  • Expected prognosis <12 months
  • Clinical or anamnestic conditions preventing participation in the rehabilitation program (dementia, non-collaboration for major psychiatric disorders, blindness, deafness, any language barriers or communication deficits that prevent participation in the program, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403075


Contacts
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Contact: Monia Allisen Accogli, PT +390522522441 moniaallisen.accogli@ausl.re.it
Contact: Monica Denti, PT +390522522441 monica.denti@ausl.re.it

Locations
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Italy
Local Health Authority - IRCCS of Reggio Emilia Recruiting
Reggio Emilia, RE, Italy, 42123
Contact: Stefania Costi, PT    0522522441      
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
GRADE Onlus
University of Modena and Reggio Emilia
Investigators
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Principal Investigator: Stefania Fugazzaro, MD AUSL - IRCCS of Reggio Emilia
Study Chair: Stefania Costi, PT AUSL - IRCCS of Reggio Emilia and University of Modena and Reggio Emilia

Publications:
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Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT03403075     History of Changes
Other Study ID Numbers: ETAF2017
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
blood cancer
exercise
therapeutic education
fatigue
feasibility
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases